NCT01784003

Brief Summary

The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

8.3 years

First QC Date

January 25, 2013

Last Update Submit

September 8, 2020

Conditions

Traumatic Amputation of Lower Extremity

Outcome Measures

Primary Outcomes (2)

  • Force-measuring treadmill and motion capture

    approximately 2 months

  • Metabolic analysis system

    approximately 2 months

Study Arms (2)

Non-amputee

People without an amputation will be recruited to participate in the study.

Below the knee amputee

People with a unilateral transtibial amputation will be recruited to participate in the study.

Device: Powered ankle-foot prosthesis

Interventions

Powered ankle-foot prosthesisDEVICE
Below the knee amputee

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Study 1: Non-amputee Study 2: Unilateral transtibial amputee Study 3: Unilateral transtibial amputee Study 4: Non-amputee Study 5: Unilateral transtibial amputee

You may qualify if:

  • Study 1:
  • \- Between 18-60 years old.
  • Study 2 and 3:
  • Between 18-60 years old.
  • At least 1 year post-amputation
  • no current problems with prosthesis or residual limb
  • At least a K3 level of ambulation
  • Study 4:
  • \- Between 18-45 years old
  • Study 5:
  • Between 18-45 years old
  • At least 1 year post-amputation
  • no current problems with prosthesis or residual limb
  • Experience running with a passive prosthesis
  • At least a K4 level of ambulation

You may not qualify if:

  • Studies 1-5
  • Cardiovascular, pulmonary, or neurological disease or disorder
  • Musculoskeletal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Related Publications (6)

  • Jeffers JR, Auyang AG, Grabowski AM. The correlation between metabolic and individual leg mechanical power during walking at different slopes and velocities. J Biomech. 2015 Aug 20;48(11):2919-24. doi: 10.1016/j.jbiomech.2015.04.023. Epub 2015 Apr 22.

    PMID: 25959113RESULT

  • Montgomery JR, Grabowski AM. The contributions of ankle, knee and hip joint work to individual leg work change during uphill and downhill walking over a range of speeds. R Soc Open Sci. 2018 Aug 29;5(8):180550. doi: 10.1098/rsos.180550. eCollection 2018 Aug.

    PMID: 30225047RESULT

  • Pickle NT, Grabowski AM, Jeffers JR, Silverman AK. The Functional Roles of Muscles, Passive Prostheses, and Powered Prostheses During Sloped Walking in People With a Transtibial Amputation. J Biomech Eng. 2017 Nov 1;139(11):1110051-11100511. doi: 10.1115/1.4037938.

    PMID: 28975280RESULT

  • Pickle NT, Grabowski AM, Auyang AG, Silverman AK. The functional roles of muscles during sloped walking. J Biomech. 2016 Oct 3;49(14):3244-3251. doi: 10.1016/j.jbiomech.2016.08.004. Epub 2016 Aug 6.

    PMID: 27553849RESULT

  • Montgomery JR, Grabowski AM. Use of a powered ankle-foot prosthesis reduces the metabolic cost of uphill walking and improves leg work symmetry in people with transtibial amputations. J R Soc Interface. 2018 Aug;15(145):20180442. doi: 10.1098/rsif.2018.0442.

    PMID: 30158189RESULT

  • Jeffers JR, Grabowski AM. Individual Leg and Joint Work during Sloped Walking for People with a Transtibial Amputation Using Passive and Powered Prostheses. Front. Robot. AI, 22 December 2017. https://doi.org/10.3389/frobt.2017.00072

    RESULT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

February 5, 2013

Study Start

June 1, 2012

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)